Intraventricular Stasis In Cardiovascular Disease

NCT04649034 | Completed

• 1 other identifier: FIBHGM-ISBIFLOW
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 3

Brief Summary

This study is designed to quantify the ventricular stasis in patients with different forms of cardiomyopathy and at risk of stroke (ischemic, non-ischemic dilated cardiomyopathy and hypertrophic cardiomyopathy) by post-processing of 2D color Doppler echocardiography and phase contrast-magnetic resonance images in order to establish the relationship between quantitative variables of intraventricular stasis and the prevalence of silent embolic events and/or intraventricular mural thrombosis.

Conditions

Dilated Cardiomyopathy; Thrombosis Cardiac; Stroke; Hypertrophic Cardiomyopathy

Keywords

Dilated cardiomyopathy; Hypertrophic cardiomyopathy; Cardiac thrombosis; Silent brain infarct; Stroke; Fluid dynamics; Intracardiac blood flow; Echocardiography; Phase contrast magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Prevalence of a combined binary variable consisting of ventricular thrombosis or silent brain infarct detected by magnetic resonance

  The primary outcome measure will be a combined binary variable consisting of one of the following findings: ventricular thrombosis assessed by cardiac magnetic resonance or silent brain infarct detected by brain magnetic resonance

  Within 10 days after enrollment

Secondary Outcomes (2)

• Left ventricle mural thrombosis assessed by cardiac magnetic resonance imaging

  Within 10 days after enrollment

• Silent brain infarcts (SBI)

  Within 10 days after enrollment

Study Arms (3)

86 patients ischemic DCM

A cohort of 86 patients with ischemic dilated cardiomyopathy in sinus rhythm and ejection fraction (EF) of LV less than 45%

Diagnostic Test: Doppler echocardiogram exam; Diagnostic Test: Cardiac magnetic resonance; Diagnostic Test: Brain magnetic resonance; Diagnostic Test: Coagulation blood test; Diagnostic Test: Holter monitoring

86 patients non ischemic DCM

A cohort of 86 patients with non-ischemic dilated cardiomyopathy in sinus rhythm and ejection fraction (EF) of LV less than 45%

Diagnostic Test: Doppler echocardiogram exam; Diagnostic Test: Cardiac magnetic resonance; Diagnostic Test: Brain magnetic resonance; Diagnostic Test: Coagulation blood test; Diagnostic Test: Holter monitoring

86 patients hypertrophic cardiomyopathy

A cohort of 86 patients with hypertrophic cardiomyopathy in sinus rhythm and ejection fraction (EF) of LV less than 55% or with an apical aneurism diagnosed in an image test

Diagnostic Test: Doppler echocardiogram exam; Diagnostic Test: Cardiac magnetic resonance; Diagnostic Test: Brain magnetic resonance; Diagnostic Test: Coagulation blood test; Diagnostic Test: Holter monitoring

Interventions

Doppler echocardiogram exam DIAGNOSTIC_TEST

A complete echocardiographic study will be performed at enrollment. The echocardiographic images will be acquired as clinically recommended. The protocol will include the acquisition of 1) 2D images in parasternal axis long and short axis; 2) 2D and Doppler tissue images in the apical planes of 4, 2 and 3 chambers; 3) Pulsed, continuous and color Doppler M (DCMM) of transmitral LV flow and LV ejection; 4) 3-Chamber apical plane with and without color Doppler; and 5) 3D LV images. DCMM images will be obtained from the apical window using 4 and 5 chamber planes. Blood flow velocity will be obtained using Color and Gray mode in the 3 chamber view during 5-10 beats in apnea.

86 patients hypertrophic cardiomyopathy; 86 patients ischemic DCM; 86 patients non ischemic DCM

Cardiac magnetic resonance DIAGNOSTIC_TEST

A cardiac MR will be acquired within 10 days after the enrollment. The protocol includes the following sequences: cine mode of short axis from LV base to apex and 2-3-4 chambers. 3D sequence of late enhancement of inversion-recovery. Images will be acquired after 3 min and 10 min of the administration of a total of 0.2 mmol / kg of Prohance®. Intraventricular thrombosis will be monitored. Phase contrast sequences in three orthogonal planes will be acquired. Morphological parameters of LV function (LVEF), contractility ("Wall Motion Score ") and sphericity index will be measured.

86 patients hypertrophic cardiomyopathy; 86 patients ischemic DCM; 86 patients non ischemic DCM

Brain magnetic resonance DIAGNOSTIC_TEST

A brain MR will be acquired within 10 days after the enrollment. Axial, sagittal and coronal spin echo sequence in T1, axial images in diffusion sequences (DWI), enhanced spin echo T2 and FLAIR (fluid-attenuated inversion recovery) sequences shall be obtained. A cerebral infarction will be positive when finding the presence of a focal lesion of\> 3 mm in diameter that meets one of these three characteristics: (1) high signal on isotropic DWI images and low signal on the apparent coefficient map Broadcast (ADC). (2) Cavitary lesion hyperintense on T2, with no signal (or low) in the FLAIR sequence. (3) Hyperintense lesion T2 / T1 hypointense with prior distribution defect known or new in a follow-up study.

86 patients hypertrophic cardiomyopathy; 86 patients ischemic DCM; 86 patients non ischemic DCM

Coagulation blood test DIAGNOSTIC_TEST

5 ml of peripheral blood will be obtained for assessment of prothrombotic markers at enrollment.

86 patients hypertrophic cardiomyopathy; 86 patients ischemic DCM; 86 patients non ischemic DCM

Holter monitoring DIAGNOSTIC_TEST

At inclusion all patients will carry a Holter device for 24 hours to ensure absence of atrial fibrillation

86 patients hypertrophic cardiomyopathy; 86 patients ischemic DCM; 86 patients non ischemic DCM

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

258 patients with diagnosis of ischemic, non ischemic dilated cardiomyopathy or hypertrophic cardiomyopathy under follow-up in the Cardiology Department of Gregorio Marañón General University Hospital, Madrid, Hospital Universitario Clínico de Salamanca and Hospital Clinic, Barcelona, who meet all of the inclusion criteria and none of the exclusion criteria will be included.

You may qualify if:

• Patients over 18 years of age.
• Sinus rhythm.
• Meet one of the following criteria:
• Diagnosis of non ischemic DCM and ejection fraction (EF) of LV less than 45%
• Diagnosis of ischemic DCM and ejection fraction (EF) of LV less than 45%
• Diagnosis of hypertrofic myocardiophathy and ejection fraction (EF) of LV less than 55% or apical aneurism diagnosed in an image test.

You may not qualify if:

• Implantable defibrillation or stimulation devices not compatible with MRI.
• Hemodinamically significant heart valve disease or prosthetic heart valves.
• Claustrophobia.
• Persistent of paroxysmal atrial fibrillation (AF).
• Prior history of significant carotid disease with stenosis greater than 50%.
• Full anticoagulation therapy prior to admission or indication of anticoagulation.
• Pro-thrombotic disorders (active oncology disease, coagulation disorders…)

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead
• University of Salamanca: collaborator
• Hospital Clinic of Barcelona: collaborator

Study Sites (3)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Universitario Clínico de Salamanca

Salamanca, 37007, Spain

Location

Related Publications (5)

• Bermejo J, Benito Y, Alhama M, Yotti R, Martinez-Legazpi P, Del Villar CP, Perez-David E, Gonzalez-Mansilla A, Santa-Marta C, Barrio A, Fernandez-Aviles F, Del Alamo JC. Intraventricular vortex properties in nonischemic dilated cardiomyopathy. Am J Physiol Heart Circ Physiol. 2014 Mar 1;306(5):H718-29. doi: 10.1152/ajpheart.00697.2013. Epub 2014 Jan 10.

  PMID: 24414062 RESULT

• Rossini L, Martinez-Legazpi P, Vu V, Fernandez-Friera L, Perez Del Villar C, Rodriguez-Lopez S, Benito Y, Borja MG, Pastor-Escuredo D, Yotti R, Ledesma-Carbayo MJ, Kahn AM, Ibanez B, Fernandez-Aviles F, May-Newman K, Bermejo J, Del Alamo JC. A clinical method for mapping and quantifying blood stasis in the left ventricle. J Biomech. 2016 Jul 26;49(11):2152-2161. doi: 10.1016/j.jbiomech.2015.11.049. Epub 2015 Nov 30.

  PMID: 26680013 RESULT

• Vermeer SE, Longstreth WT Jr, Koudstaal PJ. Silent brain infarcts: a systematic review. Lancet Neurol. 2007 Jul;6(7):611-9. doi: 10.1016/S1474-4422(07)70170-9.

  PMID: 17582361 RESULT

• Martinez-Legazpi P, Rossini L, Perez Del Villar C, Benito Y, Devesa-Cordero C, Yotti R, Delgado-Montero A, Gonzalez-Mansilla A, Kahn AM, Fernandez-Aviles F, Del Alamo JC, Bermejo J. Stasis Mapping Using Ultrasound: A Prospective Study in Acute Myocardial Infarction. JACC Cardiovasc Imaging. 2018 Mar;11(3):514-515. doi: 10.1016/j.jcmg.2017.06.012. Epub 2017 Oct 5. No abstract available.

  PMID: 28917683 RESULT

• Delgado-Montero A, Martinez-Legazpi P, Desco MM, Rodriguez-Perez D, Diaz-Otero F, Rossini L, Perez Del Villar C, Rodriguez-Gonzalez E, Chazo C, Benito Y, Flores O, Antoranz JC, Fernandez-Aviles F, Del Alamo JC, Bermejo J. Blood Stasis Imaging Predicts Cerebral Microembolism during Acute Myocardial Infarction. J Am Soc Echocardiogr. 2020 Mar;33(3):389-398. doi: 10.1016/j.echo.2019.09.020. Epub 2019 Dec 5.

  PMID: 31813676 RESULT

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Stroke; Cardiomyopathy, Hypertrophic

Interventions

Blood Coagulation Tests; Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Javier Bermejo Thomas, MD, PhD

  Hospital General Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiac Imaging. Principal Investigator.

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: November 24, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

ES (3)